ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31061 results sorted by trial registration date.
  • Effects of Therapeutic Ultrasound on Breastmilk Composition

    Inflammatory conditions of the lactating breast (ICLB) can affect up to 33% of breastfeeding mothers in the early post-partum period and are associated with pain, redness, flu-like symptoms, and fever. Physiotherapy intervention has an important role in the treatment of ICLB, which most commonly includes therapeutic ultrasound (TUS). TUS can produce heat and other non-thermal effects through sound wave energy which may assist in resolution of ICLB by reducing inflammation, accelerating tissue healing, clearing blocked ducts and other antimicrobial properties. Breastmilk contains numerous important components that combine to create the optimal nutritional source for infants. The most abundant of these components include water (87%), lactose (7%), fat (4%) and protein (1%). As TUS generates heat in the lactating breast, there is concern from Physiotherapists providing TUS and the mothers receiving it, that breastmilk composition may be affected. This is a quasi-experimental study with pre-post measures taken in a single session. Mothers will provide hand expressed breast milk samples pre and post application of continuous therapeutic ultrasound at 1MHz and at the highest clinically used intensity within Australia of 2.2Wcm2. Protein (g/L), lactose (g/L) and fat (g/L) concentrations will be analysed from the milk samples collected before and after TUS. The primary hypothesis of this study is that protein, lactose and fat concentrations within breastmilk will not change significantly before and after the application of TUS to the breast.

  • Choosing your own digital intervention for recurrent binge eating

    In digital intervention trials for binge eating, each participant is provided with a standard program. This one-size-fits-all approach does not take into account participant preferences and needs. One way to potentially improve treatment outcomes and increase intervention usage is to give participants the opportunity to select from multiple digital intervention programs based on their preferences, needs, and symptom profile. Whether such preferences can translate to better outcomes has yet to be demonstrated. In this trial, we will experimentally test whether treatment outcomes can be improved by allowing participants to choose which intervention program they want to work through. The following hypothesis was derived. Participants allocated to the preferred condition (i.e., can select from two digital programs they want to receive) will demonstrate better retention, engagement, and primary and secondary symptom reduction than participants allocated to the forced condition (i.e., where they will be administered one of the two digital programs at random).

  • Screening and Support for Health and General Anxiety at the Prince of Wales Hospital - An Exploratory Study

    This project aims to examine the acceptability of new treatments for health anxiety in a medical outpatient setting. It will also link participant data to NSW Health records to examine trends in hospital usage. The study can be broken into three parts. Screening (Step-1) - patients attending one of four clinics at the Prince of Wales Hospital asked to complete digital screening for health anxiety. We hypothesise that: 1. Digital screening for anxiety will be acceptable to medical outpatients. 2. Between 20-25% of medical outpatients will have elevated anxiety scores. SHAPE Pilot (Step-2)- those who are identified to have elevated health anxiety will be called by a researcher and invited to partake in an iCBT intervention or intervention with a clinician. Follow-up measures will be taken at 6, 12, and 24 weeks to monitor the effect of the interventions. We hypothesise that: 1. The novel care pathway for health anxiety will be acceptable. 2. The novel care pathway for health anxiety will result in a reduction in health anxiety measures. Data linkage- We will collaborate with the Centre for Health Record Linkage (CHeReL), to link participant data to data regarding health care utilisation. This will be used to examine relationships between health anxiety and health care utilisation. We hypothesise that group level data linkage will show: 1. Higher rates of health care utilisation according to health anxiety self-report measures. 2. Concordance between actual and self-reported rates of health care utilisation in general.

  • Kaat Koort: Examining the impact of a program targeting cardio-metabolic risk and lifestyle changes on heart and brain health among Aboriginal and Torres Strait Islander people

    Limited data that are available indicate that Indigenous Australians have a dementia prevalence three times higher than the general Australian population. The major risk factors for dementia and cognitive decline – the slowing of brain function and memory – are known and are elevated in older Indigenous Australians. Many of these risk factors can be targeted for prevention. During the recent two decades, several studies have shown a relationship between the development of cognitive decline and dementia with lifestyle-related risk factors, such as: physical inactivity, tobacco use, unhealthy diets, and harmful use of alcohol. Certain chronic conditions are also associated with an increased risk of cognitive decline and developing dementia, including hypertension, diabetes, hypercholesterolemia, obesity and depression. Other potentially modifiable risk factors are social isolation and cognitive inactivity. The existence of potentially modifiable risk factors means that prevention of cognitive decline and dementia is possible through a public health approach, including the implementation of key interventions that delay or slow cognitive decline. Prevention of dementia and cognitive decline requires the management of cardiovascular risk factors and dementia-specific risk factors, as well as building on current primary care interventions. Rather than address individual risk factors in isolation, our study is planning to adopt a multi-domain approach that targets multiple risk factors simultaneously to maximise the potential for risk reduction.

  • Determining whether Deep Learning Analysis of Facial Imaging is Effective in Predicting Difficult Intubation

    When a patient has surgery under general anaesthesia, it is one of the jobs of the anaesthetist to secure and maintain a patent airway. Placing a breathing tube into a patients’ windpipe is one of the most commonly performed procedures to secure the patient’s airway. Though this so-called intubation is usually an easy task for the anaesthetist, sometimes it can be difficult. This leads to a potentially life-threatening situation. Hence, it is part of the routine preoperative anaesthetic assessment to examine a patients’ airway in order to attempt to predict how difficult it will be to intubate them. There are a number of examination techniques and tools that have been developed for this, but none are sensitive enough to rely on. Deep learning algorithms are able to learn to map complex and subtle relationships between input variables to a known output. This relationship is learned from the data, and the algorithm can then be used to predict outputs for future inputs. Deep learning algorithms have been successfully applied to a wide range of computer vision tasks This research will apply deep learning to patients basic demographics and photographs of patients face and neck in order to predict how difficult they will be to intubate. We will recruit patients from the perioperative anaesthetic assessment clinic at Royal Perth Hospital who are expected to require intubation for their surgery. We will take 3-dimensional stereophotographs of the patients’ face and neck in various positions. The difficulty of intubation will be recorded at the time of surgery. We train the deep learning model using simple patient data such as age, gender height, weight, and the images as an input, and the intubation difficulty as an output. We will then attempt to predict how difficult intubation will be for patients given their images as an input. We will also compare the results of the deep learning algorithm to anaethetists predictions.

  • The ARISTOCRAT Registry- The Australian natural history of pericoronary adipose tissue attenuation, radiomics and plaque by computed tomographic angiography

    CT coronary angiogram (CTCA) is increasingly used as a non-invasive imaging tool to assess the efficacy of novel therapies on coronary inflammation as well as plaque progression, and it is imperative that we understand the natural history of pericoronary adipose tissue (PCAT) inflammation on serial assessment. The ARISTOCRAT registry is a retrospective and prospective, open-label, multi-centre dynamic observational registry designed to directly assess the natural history of PCAT inflammation, coronary atherosclerosis, characteristics, and determinants of coronary plaque progression.

  • Effect of personalised music listening on quality of life and cognitive abilities in persons with dementia

    This project will address basic questions regarding the use of daily music listening to improve the quality of life for people with dementia (PWD). It will be the first study to examine the role of how often (and for how long) music listening influences the quality of life of people with dementia using short- and longer-term follow-ups. Sixty participants (with dementia) will be randomly assigned to one of five groups. The groups will include personalised daily music listening with headphones (once or twice daily), audiobook listening with headphones, contemporary music (not personalised), and not wearing headphones or listening to music. All participants will receive their standard care. Expected outcomes include improved quality of life for people with dementia, decreased behavioural disturbances and increased cognitive functioning. This study will examine the effects of listening to personalised music to improve quality of life and behaviour in persons with dementia. We hypothesise personalised music listening will improve the quality of life and behaviour of people with dementia. This hypothesis will be examined by asking the following questions: 1. Does daily exposure of listening to personalised and preferred music via headphones improve quality of life indices in people with dementia? 2. Does daily exposure of listening to personalised and preferred music via headphones reduce the severity and frequency of symptoms (e.g., agitation, anxiety and depression) in people with dementia within residential aged-care facilities? 3. How long after the intervention ceases are any positive outcomes still measurable? Is this period affected by the frequency and duration of the personalised music intervention?

  • Effect of fluid restriction on incidence of delayed hyponatraemia post pituitary surgery

    This study is investigating the efficacy of prophylactic fluid restriction for prevention of low sodium levels after pituitary surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older and are undergoing pituitary surgery for a pituitary tumour (functional and non-functional pituitary adenomas, Rathke’s cleft cyst, craniopharyngioma, other). Study details Participants will be randomly allocated to either a fluid restriction protocol (1L of fluid per day for days 4-9 post-pituitary surgery) or a protocol of no fluid restriction. Blood samples as well as data on hospital readmission rates and adverse events will be collected and analysed. It is hoped that information from this study will help inform future management of pituitary surgery patients and prevention of electrolyte disturbances.

  • Efficacy of individual cognitive rehabilitation for adult cancer survivors: A pilot study

    Some people who have been treated for non-central nervous system cancers experience problems with cognitive function during and/or after treatment. In this project, an education and skills intervention that was previously delivered successfully for this population by psychologists or occupational therapists in small group format (Responding to Cognitive Concerns, ReCog) and individual online format (eReCog) will be adapted for individual face-to-face delivery by appropriate professionals (ReCog-I) and piloted with a small number of people who have been treated for cancer. This research aims to gather initial evidence about whether the ReCog-I program has an influence on perceived cognitive function and mental health in participants who have been treated for cancer.

  • A randomised controlled trial of a wellbeing app in the general public

    This is a 12-week RCT trial involving a 6-week wellbeing program delivered via the app. The trial will recruit healthy adults from the app user base with the aim of measuring the participants’ levels of mental wellbeing over time and determining whether the app is effective at increasing their wellbeing, compared to an active control version of the app.

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